Device and method for providing a bone cement dough

Abstract

Device (100, 100') for providing a bone cement dough (500) from two starting components, comprising a mixing unit (200, 200') with an interior space (210, 210') in which a bone cement powder (510, 510') is stored or can be stored as the first starting component, a reservoir (300, 300') with a reservoir container (310, 310') in which at least one fluid-conducting closed monomer liquid container (320, 320') filled with a monomer liquid (520, 520') is stored or can be stored as the second starting component, a transfer unit (400, 400') comprising a hollow cylinder (410, 410') and a delivery piston (420, 420') which can be displaced axially in the hollow cylinder (410, 410'), wherein the mixing unit (200, 200') and the reservoir (300, 300') are or can be connected to one another in a fluid-conducting manner via the hollow cylinder (410, 410'), wherein the monomer liquid container (320, 320') in the device (100, 100') can be opened in such a way that the monomer liquid (520,520') from the reservoir (300, 300') into the hollow cylinder (410, 410') via a passage (330, 330') and can be conveyed from the hollow cylinder (410, 410') into the interior (210, 210') by axial displacement of the delivery piston (420, 420') in the hollow cylinder (410, 410'), characterized in that in a first configuration of the device (100, 100'), the delivery piston (420, 420') is connected to an opening means (430, 430'), so that axial displacement of the delivery piston (420, 420') from a first position to a second position pushes the opening means (430, 430') against the monomer liquid container (320, 320'), so that the monomer liquid container (320, 320') can be opened in a fluid-conducting manner by the opening means (430, 430') and the monomer liquid (520, 520') can flow from the reservoir (300, 300') via the passage (330, 330') into the hollow cylinder (410, 410'), and that in a second configuration of the device (100,100') the delivery piston (420, 420') is separated from the opening means (430, 430'), so that the monomer liquid (520, 520') can be delivered from the hollow cylinder (410, 410') into the interior (210, 210') by a continued axial displacement of the delivery piston (420, 420') from the second position towards a third position.

Description

[0001] The invention relates to a device for providing a bone cement dough from two starting components, comprising a mixing unit with an interior space in which a bone cement powder is stored or can be stored as the first starting component, a reservoir with a reservoir container in which at least one fluid-conducting closed monomer liquid container filled with a monomer liquid is stored or can be stored as the second starting component, a transfer unit comprising a hollow cylinder and a delivery piston that can be moved axially in the hollow cylinder, wherein the mixing unit and the reservoir are or can be connected to one another in a fluid-conducting manner via the hollow cylinder, wherein the monomer liquid container in the device can be opened in such a way that the monomer liquid can flow from the reservoir into the hollow cylinder via a passage and can be conveyed from the hollow cylinder into the interior space by axially displacing the delivery piston in the hollow cylinder.

[0002] The invention further relates to a method for providing a bone cement dough from two starting components by means of such a device. Background of the invention

[0003] Considerable efforts are being made to develop devices and methods for providing bone cement that allow for simple, reliable, and rapid preparation. An important aspect of bone cement preparation is the avoidance of air inclusions, such as gas bubbles, in the bone cement. To avoid this, a variety of vacuum cementing systems have been described, of which the following are examples: US 6,033,105 A, US 5,624,184 A, US 4,671,263 A, US 4,973,168 A, US 5,100,241 A, WO 99 / 67015 A1, EP 1020167 A2, US 5,586,821 A, EP 1016452 A2, DE 3640279 A1, WO 94 / 26403 A1, EP 1005901 A2, EP 1886647 A1, US 5,344,232 A.

[0004] There is a desire in the market to simplify the preparation of bone cement dough. One further development is the development of cementing systems in which both starting components are stored in separate areas of the mixing system and are only mixed together in the cementing system immediately before cementing application. Such closed, so-called fully prepacked systems are mentioned, for example, in the following publications: EP 0 692 229 A1, DE 10 2009 031 178 B3, US 5,997,544 A, US 6,709,149 B1, DE 698 12 726 T2, EP 0 796 653 A2, US 5,588,745 A.

[0005] In the aforementioned fully prepacked systems, a monomer liquid is mixed with a bone cement powder by mechanical mixing, for example using a mixing rod.

[0006] Patent application EP 3 093 067A1 describes another device for preparing a bone cement dough. The device comprises a mixing unit in which a bone cement powder is stored as the first starting component and a reservoir in which a monomer liquid is stored as the second starting component in an ampoule. The mixing unit is fluidly connected to the reservoir via a hollow cylinder of a transfer unit. After the ampoule is fluidly opened by bending the reservoir, the monomer liquid can flow into the hollow cylinder, from where it can be conveyed into the mixing unit by axially displacing a conveying piston of the transfer unit in the hollow cylinder. A disadvantage of such a system is that the steps of fluidly opening and conveying the monomer liquid from the hollow cylinder into the mixing unit can take place simultaneously.This can result in, for example, the pumping process being triggered before all the monomer fluid has flowed from the reservoir into the hollow cylinder, resulting in undesirable compositions of the bone cement mixture, for example, due to incomplete pumping of the monomer fluid. The device is therefore susceptible to operating errors.

[0007] There is therefore a desire in the market for further simplification of devices for preparing bone cement dough and, in particular, for safe-to-use devices that exclude operating errors as far as possible. Tasks

[0008] An object of the present invention is to at least partially overcome one or more of the disadvantages resulting from the prior art.

[0009] Specifically, the invention is based on the objective of providing a device that enables simple and reliable preparation of a bone cement dough. In particular, the device should enable the desired amount of monomer liquid to be pumped into a bone cement powder as reliably as possible, so that a bone cement dough with a desired mixing ratio of these two starting components can be prepared. In particular, the opening of a monomer liquid container filled with the monomer liquid should be carried out with as little effort as possible and while avoiding the need for additional, separate tools. Furthermore, the opening of the monomer liquid container should be possible with as few components as possible. Furthermore, the monomer liquid should be available for preparing the bone cement dough with as little loss and as quickly as possible.The transfer of monomer liquid into bone cement powder to prepare the bone cement paste should be carried out with as little force as possible. The device should be operated with as simple steps as possible and as safe as possible.

[0010] It is a further object of the invention to provide a method by which bone cement can be provided from two starting components, by means of which at least some of the objects already described are at least partially achieved. Preferred embodiments of the invention

[0011] A contribution to at least partially fulfilling at least one of the aforementioned objects is made by the features of the independent claims. The dependent claims provide preferred embodiments that contribute to at least partially fulfilling at least one of the objects.

[0012] A first embodiment of the invention is a device for providing a bone cement dough from two starting components, comprising a mixing unit with an interior space in which a bone cement powder is stored or can be stored as the first starting component, preferably a reservoir with a reservoir container in which at least one fluid-conducting closed monomer liquid container filled with a monomer liquid as the second starting component is stored or can be stored, preferably a transfer unit comprising a hollow cylinder and a delivery piston that can be moved axially in the hollow cylinder, wherein the mixing unit and the reservoir are or can be connected to one another in a fluid-conducting manner via the hollow cylinder, wherein the monomer liquid container can be opened in the device in such a way that the monomer liquid can flow from the reservoir into the hollow cylinder via a passage and can be moved from the hollow cylinder into the interior space by axially moving the delivery piston in the hollow cylinder, characterized in thatthat in a first configuration of the device, the feed piston is connected to an opening means, so that an axial displacement of the feed piston from a first position into a second position pushes the opening means against the monomer liquid container, so that the monomer liquid container can be opened in a fluid-conducting manner by the opening means and the monomer liquid can flow from the reservoir via the passage into the hollow cylinder, and that in a second configuration of the device, the feed piston is separate from the opening means, so that the monomer liquid can be conveyed from the hollow cylinder into the interior by a continued axial displacement of the feed piston from the second position towards a third position.

[0013] In one embodiment of the device, in the first configuration, the delivery piston is only displaceable between the first position and the second position. This embodiment is a second embodiment of the invention, which preferably depends on the first embodiment of the invention.

[0014] In one embodiment of the device, in the first configuration, the opening means rests against a stop in the second position of the delivery piston, so that the continued axial displacement of the delivery piston from the second position toward the third position is prevented. This embodiment is a third embodiment of the invention, which preferably depends on the second embodiment of the invention.

[0015] In one embodiment of the device, the opening means is a wedge. This embodiment is a fourth embodiment of the invention, which preferably depends on one of the preceding embodiments of the invention.

[0016] In one embodiment of the device, the wedge has at least one passage, allowing the monomer liquid to flow from the reservoir into the hollow cylinder through the opening and the passage. This embodiment is a fifth embodiment of the invention, which preferably depends on the fourth embodiment of the invention.

[0017] In one embodiment of the device, the monomer liquid container is an ampoule, preferably a glass ampoule, and is stored in the reservoir container, wherein the opening means is arranged axially above an ampoule head of the ampoule, so that when the delivery piston is displaced from the first position to the second position in the first configuration of the device, the opening means can be pressed or pushed against the ampoule head, thus opening the ampoule in a fluid-conducting manner. This embodiment is a sixth embodiment of the device, which preferably depends on one of the preceding embodiments of the invention.

[0018] In one embodiment of the device, the delivery piston and the opening means are connected to each other via a driver in the first configuration. This embodiment is a seventh embodiment of the device, which preferably depends on one of the preceding embodiments of the invention.

[0019] In one embodiment of the device, the driver is separated from the opening means when the device is moved from the first configuration to the second configuration. This embodiment is an eighth embodiment of the device, which preferably depends on the seventh embodiment of the invention.

[0020] In one embodiment of the device, the preferably reversible transfer of the device from the first configuration to the second configuration is achieved by rotating the delivery piston about a delivery piston longitudinal axis. This embodiment is a ninth embodiment of the invention, which preferably depends on the eighth embodiment of the invention.

[0021] In one embodiment of the device, the driver is arranged on a ring around the delivery piston, so that the device can be moved from the first configuration to the second configuration by rotating the ring around the delivery piston. This embodiment is a tenth embodiment of the invention, which preferably depends on the eighth embodiment of the invention.

[0022] In one embodiment of the device, the device has a transport lock that prevents accidental displacement of the opening means. This embodiment is an eleventh embodiment of the invention, which preferably depends on one of the preceding embodiments of the invention.

[0023] In one embodiment of the device, the delivery piston has at least one detachable, preferably reversibly detachable, control element that limits the displacement of the delivery piston between the second position and the third position to an intermediate position, in particular to an intermediate position spatially between the second position and the third position. This embodiment is a twelfth embodiment of the invention, which preferably depends on one of the preceding embodiments of the invention.

[0024] In one embodiment of the device, the delivery piston closes the passage in a fluid-conducting manner upon axial displacement from the second position toward the third position. This embodiment is a thirteenth embodiment of the invention, which preferably depends on one of the preceding embodiments of the invention.

[0025] A fourteenth embodiment of the invention is a method for providing a bone cement dough from two starting components by means of a device according to one of the embodiments one to thirteen of the invention, wherein a bone cement powder is stored in the interior as the first starting component and a fluid-conducting closed monomer liquid container filled with a monomer liquid as the second starting component is stored in the reservoir container, comprising the method steps: a. Providing the device in the first configuration; b. Axial displacement of the feed piston from the first position to the second position while fluidically opening the monomer liquid container; c. Flow of the monomer liquid from the reservoir into the hollow cylinder; d. Moving the device from the first configuration to the second configuration; e. Axial displacement of the feed piston from the second position towards the third position while conveying the monomer liquid from the hollow cylinder into the interior; f. Mixing the bone cement powder and the monomer liquid in the mixing unit while providing the bone cement dough.

[0026] In one embodiment of the method, the device is moved from the first configuration to the second configuration by a rotational movement. This embodiment is a fifteenth embodiment of the invention, which preferably depends on the fourteenth embodiment of the invention. General

[0027] In this description, range specifications also include the values ​​referred to as limits. A specification such as "in the range from X to Y" with respect to a quantity A therefore means that A can assume the values ​​X, Y, and values ​​between X and Y. Unilaterally limited ranges such as "up to Y" for a quantity A correspondingly mean the value Y and less than Y.

[0028] Some of the described features are linked to the term "essentially." The term "essentially" is to be understood in such a way that, under real-world conditions and manufacturing techniques, a mathematically precise interpretation of terms such as "superposition," "perpendicular," "diameter," or "parallelism" can never be exact, but only within certain manufacturing error tolerances. For example, "essentially perpendicular axes" enclose an angle of 85 degrees to 95 degrees to each other, and "essentially equal volumes" encompass a deviation of up to 5% by volume. A "device consisting essentially of plastic," for example, comprises a plastic content of ≥95 to ≤100% by weight. A "substantially complete filling of a volume B," for example, encompasses a filling of ≥95 to ≤100% by volume of the total volume of B.

[0029] The terms "proximal" and "distal" merely refer to the spatially opposite ends of the device or other structural units of the device and do not allow any conclusions to be drawn about the orientation relative to a human body, for example, a user of the device. Accordingly, "distal to..." and "proximal to..." or similar formulations merely express the spatial arrangement of two structural units of the device relative to each other. Detailed description

[0030] A first subject of the invention relates to a device for providing a bone cement dough from two starting components, comprising a mixing unit with an interior space in which a bone cement powder is stored or can be stored as the first starting component, a reservoir with a reservoir container in which at least one fluid-conducting closed monomer liquid container filled with a monomer liquid is stored or can be stored as the second starting component, a transfer unit comprising a hollow cylinder and a delivery piston that can be moved axially in the hollow cylinder, wherein the mixing unit and the reservoir are or can be connected to one another in a fluid-conducting manner via the hollow cylinder, wherein the monomer liquid container can be opened in the device in such a way that the monomer liquid can flow from the reservoir into the hollow cylinder via a passage and can be conveyed from the hollow cylinder into the interior space by axially displacing the delivery piston in the hollow cylinder, characterized in thatthat in a first configuration of the device, the feed piston is connected to an opening means, so that an axial displacement of the feed piston from a first position into a second position pushes the opening means against the monomer liquid container, so that the monomer liquid container can be opened in a fluid-conducting manner by the opening means and the monomer liquid can flow from the reservoir via the passage into the hollow cylinder, and that in a second configuration of the device, the feed piston is separate from the opening means, so that the monomer liquid can be conveyed from the hollow cylinder into the interior by a continued axial displacement of the feed piston from the second position towards a third position.

[0031] Preferably, both the bone cement powder and at least one monomer liquid container are stored in the device.

[0032] The device is used to mix a bone cement dough from a bone cement powder and a monomer liquid. Prior to mixing, the bone cement powder can be stored, or preferably is stored, in a mixing unit of the device, and the monomer liquid can be stored, or preferably is stored, in a reservoir of the device. Preferably, the monomer liquid is located in the reservoir, in particular in a reservoir container of the reservoir, within one or more monomer liquid containers. The reservoir container is designed to store this or these monomer liquid containers safely and sterilely.

[0033] A monomer liquid container is a vessel for the monomer liquid in which it can be stored safely and, in particular, sterilely until use. Various monomer liquid containers are known to those skilled in the art.

[0034] For example, the monomer liquid container can be a bag. Preferred bags are multilayer composite films with an EVOH (ethylene vinyl alcohol) barrier layer, optionally comprising a metal coating, in particular comprising an aluminum coating.

[0035] The monomer liquid container is preferably an ampoule, preferably a glass ampoule. Ampoules are preferred because they are more controllable and facilitate complete discharge of the monomer liquid from fluid-opened ampoules.

[0036] The mixing unit serves to mix the bone cement dough from the bone cement powder and the monomer liquid after conveying the monomer liquid into the mixing unit, in particular after conveying the monomer liquid into an interior of the mixing unit in which the bone cement powder is preferably stored.

[0037] The mixing unit preferably has a hollow cylindrical cartridge. A hollow cylindrical cartridge is understood to be a tube-like container having an interior and a cartridge wall surrounding the interior. The cross-section of the cartridge can take on any shape. Due to the ease of manufacture and safer use of the device, the cross-section, and preferably also the cross-section of the interior, is circular. This allows for good handling for the user and, due to the absence of edges, reduces the risk of jamming of moving parts within the device. According to the invention, the cartridge can be made of a wide variety of materials or material combinations. For example, the device can be made of a polymer.Preferably, the polymer is a transparent polymer, as this allows the user to visually check the proper functioning of the device during use.

[0038] In order to mix the bone cement dough from the two starting materials in the mixing unit, a mixing element that can be reversibly moved axially within the interior is preferably arranged in the interior. Reversible back and forth movement of the mixing element within the interior leads to the most homogeneous mixing possible of the bone cement powder and the monomer liquid, thereby producing the bone cement dough. For example, the mixing element can be a mixing rod, with rotor-like mixing blades arranged at one end of the mixing rod located within the interior. Preferably, the mixing rod is also mounted within the interior so that it can rotate about its longitudinal axis, so that such rotation of the mixing blades can support the mixing process of the two starting components.

[0039] The mixing unit preferably has a discharge opening from which the bone cement dough provided in the mixing unit can be discharged. The mixing unit is preferably fluidly connected to the transfer unit via the discharge opening, preferably via a connecting line, such as a hose. To discharge the bone cement dough from the mixing unit, it is therefore preferable to detach the mixing unit from the rest of the device, in particular the transfer unit and also the hose between the mixing unit and the transfer unit, so that the bone cement dough can be discharged through the discharge opening.

[0040] To discharge the bone cement dough, the mixing unit preferably has a conveying piston that can move axially in the interior.

[0041] The transfer unit is arranged in a fluid-conducting manner between the reservoir and the mixing unit. The transfer unit has a hollow cylinder and a delivery piston that can be moved axially within the hollow cylinder. The hollow cylinder is fluid-conductingly connected to the reservoir, in particular the reservoir container, via a passage so that the monomer liquid from a monomer liquid container that is fluid-conductingly open in the reservoir can flow via the passage into the hollow cylinder. The hollow cylinder is designed to completely absorb the monomer liquid stored in the reservoir when the device is in use. There is also a fluid-conducting connection between the hollow cylinder and the mixing unit so that the monomer liquid in the hollow cylinder can be transferred into the mixing unit. The hollow cylinder is preferably fluid-conductingly connected to the mixing unit via a connecting line, preferably a hose.Preferably, the connecting line between the transfer unit and the mixing unit is arranged in a loop with a high apex in order to prevent an uncontrolled flow of the monomer liquid through the connecting line into the mixing unit, in particular the interior.

[0042] The monomer liquid located in the hollow cylinder thus preferably remains within the hollow cylinder until a user of the device actively intervenes to convey the monomer liquid into the mixing unit, in particular the interior.

[0043] To convey the monomer liquid from the hollow cylinder into the mixing unit, in particular the interior, the transfer unit has a conveying piston. The conveying piston is axially displaceable within the hollow cylinder and, together with the hollow cylinder, forms a piston-cylinder system for conveying the monomer liquid. Preferably, the connecting line is located at an axial end of the hollow cylinder, so that displacement of the conveying piston toward the connecting line can cause a substantially complete conveying of the monomer liquid from the hollow cylinder into the mixing unit.

[0044] The reservoir, in particular the reservoir container, serves to store the monomer liquid container filled with the monomer liquid, whereby the monomer liquid container remains fluidly closed until use. To open the fluidly closed monomer liquid container in a fluidly conductive manner, the device has an opening means. The opening means is designed for the type and nature of the monomer liquid container, but is configured such that pushing, or in other words "pressing," the opening means against the monomer liquid container overcomes its structural integrity and thus opens it in a fluidly conductive manner. For this purpose, the opening means preferably has a pointed or sharp-edged side or surface that is slidably mounted against the monomer liquid container. The opening means is preferably arranged within the reservoir so that it can be moved into contact with the monomer liquid container.

[0045] In a first configuration of the device, the delivery piston is connected to the opening means such that an axial displacement of the delivery piston from a first position, in particular from a first spatial position within the hollow cylinder, to a second position, in particular into a second spatial position within the hollow cylinder, pushes the opening means against the monomer liquid container and can thus open it in a fluid-conducting manner. This means that in the first configuration, a movement of the delivery piston is transmitted to the delivery piston. In other words, the opening means can be operated via the delivery piston in the first configuration. Preferably, an axial displacement of the delivery piston within the hollow cylinder leads to a similar displacement of the opening means within the reservoir, preferably by the same distance.

[0046] In a second configuration of the device, the delivery piston is separate from the opening means. Thus, unlike in the first configuration, a movement, in particular an axial displacement of the delivery piston within the hollow cylinder, does not result in a displacement of the opening means.

[0047] In the second configuration, a continued axial displacement, i.e. a displacement in the same direction, of the delivery piston from the second position towards a third position, in particular towards a third spatial position within the hollow cylinder, leads to a conveyance of the monomer liquid located in the hollow cylinder into the mixing unit, in particular the interior of the mixing unit.

[0048] The device thus has two different configurations. The first configuration serves to fluidically open the monomer liquid container and thus to flow the monomer liquid from the reservoir into the hollow cylinder of the transfer unit, while the second configuration serves to convey the monomer liquid from the transfer unit into the mixing unit. The two configurations of the device thus functionally and, due to the time delay caused by the configuration change, temporally separate the two process steps for preparing the bone cement dough, which increases the safety of use of the device for a user. In particular, this reduces the risk of the user triggering the conveyance of the monomer liquid before it has essentially completely flowed from the reservoir into the transfer unit.

[0049] One embodiment of the device is characterized in that, in the first configuration, the delivery piston can only be moved between the first position and the second position. To convey the monomer liquid from the transfer unit to the mixing unit, the device in this embodiment must be in the second configuration, which further increases application safety. In the first configuration, however, only a fluid-conducting opening of the monomer liquid container is possible, but not the conveyance of the monomer liquid from the transfer unit to the mixing unit.

[0050] The device can be designed differently so that the conveying of the monomer liquid from the transfer unit into the mixing unit is possible only in the second configuration, but not in the first configuration.

[0051] One embodiment of the device is characterized in that, in the first configuration, the opening means rests against a stop in the second position of the delivery piston, such that continued axial displacement from the second position towards the third position is prevented. The stop prevents continued displacement of the opening means. Since the opening means is connected to the delivery piston in the first configuration, the blocked opening means ensures that the delivery piston cannot be displaced from the second position towards the third position. Since the delivery of the monomer liquid only begins when the delivery piston is moved from the second position towards the third position, the stop ensures that delivery is not possible in the first configuration of the device.This increases the application safety of the device, since an active switching from the first configuration to the second configuration is necessary to initiate the conveying of the monomer liquid into the mixing unit.

[0052] The stop can be positioned at different points on the opening means in the second position of the delivery piston to block the delivery piston in the direction of the third position. For example, the stop can be a wall within the reservoir against which an end of the opening means facing the monomer liquid container, which was used for fluid-conducting opening, abuts in the second position of the delivery piston. The stop can also be a projection inside or outside the reservoir against which a protrusion on the opening means abuts in the second position of the delivery piston, thus blocking it. This protrusion can also be arranged at an end of the opening means facing away from the monomer liquid container.

[0053] The opening means can be designed in various ways to open the monomer liquid container in a fluid-conducting manner. In particular, the design of the opening means depends on the type of monomer liquid container. For example, the opening means can be a spike, which is particularly preferred when using a bag as the monomer liquid container.

[0054] One embodiment of the device is characterized in that the opening means is a wedge. The wedge has at least one, preferably sharp-edged, edge, at least in the direction of the monomer liquid container, in this case preferably an ampoule, which facilitates opening of the monomer liquid container.

[0055] One embodiment of the device is characterized in that the wedge has at least one opening, in particular a fluid-conducting opening, so that the monomer liquid can flow through the opening and the passage from the reservoir into the hollow cylinder. Depending on the design of the device, the opening means in the form of a wedge can make it more difficult for the monomer liquid to flow out of the monomer liquid container, preferably in the form of an ampoule, after the monomer liquid container has been opened, since the wedge is located in the natural flow path of the monomer liquid in the direction of the passage, and thus in the direction of the transfer unit. In such a design, the at least one opening ensures improved flowability of the monomer liquid. For example, the opening is in the form of a hole in the wedge.In a further embodiment, the opening divides one edge of the wedge into two edge sections, so that the monomer liquid can flow between these edge sections.

[0056] One embodiment of the device is characterized in that the monomer liquid container is an ampoule, preferably a glass ampoule, and is stored in the reservoir container, and in that the opening means is arranged axially above an ampoule head of the ampoule, so that when the delivery piston is moved from the first position to the second position in the first configuration of the device, the opening means can be pressed against the ampoule head, thus opening the ampoule in a fluid-conducting manner. In this embodiment, the ampoule and the opening means are aligned with one another such that, during proper use, the opening means presses against the ampoule head of the ampoule and opens the ampoule in a fluid-conducting manner in the region of the ampoule head, preferably at an ampoule neck of the ampoule.In ampoules known to those skilled in the art, particularly glass ampoules, for monomer liquids, an ampoule body, which can hold the majority of the monomer liquid, is connected to the ampoule head via a narrow ampoule neck. The ampoule neck represents a predetermined breaking point of the ampoule, at which it can be opened easily and in a controlled manner. Typically, pressure is exerted against the ampoule head, causing it to break off at the ampoule neck.

[0057] The delivery piston and the opening means may be connected to each other in different ways in the first configuration of the device, so that a displacement of the delivery piston causes a displacement of the opening means.

[0058] One embodiment of the device is characterized in that, in the first configuration, the delivery piston and the opening means are connected to each other via a driver. A driver is a structural unit of the device that establishes a direct connection between the delivery piston and the opening means. The driver thus leads to a synchronous, concurrent displacement of the delivery piston and the opening means by an equal distance.

[0059] In this embodiment, a change from the first configuration to the second configuration can occur in different ways. For example, the driver can be released from both the delivery piston and the opening means, so that the delivery piston and the opening means are no longer connected to each other. Or the driver can be released from the delivery piston, but not from the opening means. This also results in the delivery piston and the opening means no longer being connected to each other, and a displacement of the delivery piston does not affect the opening means.

[0060] One embodiment of the device is characterized in that the driver is separated, or in other words, released, from the opening means when the device is moved from the first configuration to the second configuration. In this embodiment, the driver preferably remains connected to the delivery piston in the second configuration.

[0061] Separating the driver from the opening means when changing from the first configuration to the second configuration can be achieved in different ways. For example, the driver can be designed to be removable from the opening means, or the driver can be designed with a detachable holder that is closed in the first configuration and open in the second configuration.

[0062] One embodiment of the device is characterized in that the device can be moved from the first configuration to the second configuration by rotating the delivery piston about a longitudinal axis of the delivery piston. Rotation about the longitudinal axis of the delivery piston thus disengages the driver from the opening means, while the driver remains connected to the delivery piston and simultaneously rotates with the delivery piston. In this embodiment, the driver is preferably engaged with the opening means in the first configuration in such a way that an axial displacement of the delivery piston, and thus also of the driver, is transmitted to the opening means, but this engagement is disengaged by rotating the delivery piston, and thus also of the driver.For example, the driver has a pin at an end facing the opening means, which, in the first configuration of the device, engages in a pin-shaped recess in the opening means, thus connecting both elements. Rotating the delivery piston causes the pin to slide out of the recess, and the driver and the opening means are no longer connected, so that the device is in the second configuration.

[0063] One embodiment of the device is characterized in that the driver is arranged on a ring around the delivery piston, in particular around a delivery piston circumference of the delivery piston, so that the device can be moved from the first configuration to the second configuration by rotating the ring around the delivery piston. This embodiment is similar to the previous embodiment, except that it is not rotating the delivery piston, but rotating the ring that releases the driver from the opening means. Although the driver remains with the delivery piston in this embodiment as well, the driver is rotatable independently of any rotational movement of the delivery piston. The ring, via which the driver is arranged on the delivery piston, can extend completely or only partially around a delivery piston circumference. For example, the ring can be a type of clamp that rotatably fastens the driver to the delivery piston.Regardless of the exact design of the ring, it always ensures that an axial displacement of the delivery piston results in a similar displacement of the driver.

[0064] One embodiment of the device is characterized in that the device has a transport lock that prevents unintentional displacement of the opening means, especially in the first configuration of the device. The transport lock thus ensures safe transport of the device, especially if the monomer liquid container is already located in the reservoir container.

[0065] To convey the monomer liquid from the hollow cylinder into the interior of the mixing unit, the feed piston in the second configuration of the device can be moved from the second position towards the third position. The feed of the monomer liquid can begin immediately when the feed piston begins to move from the second position towards the third position. The feed of the monomer liquid can also only begin after the feed piston has already covered a section between the second position and the third position. For example, if this section is not filled with monomer liquid but with gas, for example air or a protective gas such as nitrogen, before the feed piston is moved. This is usually determined by the volume of the hollow cylinder as a function of the amount of monomer liquid used.

[0066] The third position can be considered the position of the delivery piston that allows for essentially complete delivery of the monomer liquid out of the hollow cylinder. Moving the delivery piston from the second position toward the third position and ultimately to the third position thus allows for partial or, upon reaching the third position, essentially complete delivery of the monomer liquid.

[0067] For example, to achieve a specific mixing ratio of bone cement powder to monomer liquid, it may be desirable not to pump all of the monomer liquid present in the monomer liquid container into the mixing unit. In these circumstances, the delivery piston should only be moved a corresponding distance from the second position to the third position, but not the entire distance to the third position.

[0068] One embodiment of the device is characterized in that the delivery piston has at least one detachable control element which limits the displacement of the delivery piston from the second position and the third position to an intermediate position. The control element thus allows a user of the device to set the position up to which the delivery piston should be displaceable in the second configuration, which has a direct impact on the amount of monomer liquid delivered from the hollow cylinder into the interior. For example, the control element can be adjusted such that the delivery piston can only be pushed into the hollow cylinder up to an intermediate position which allows half the amount of monomer liquid present in the hollow cylinder to be delivered.

[0069] The control element can be, for example, a clamp, a sleeve, a tensioning device or a clamp, which can be releasably fastened to an outer side of the delivery piston and thus limits a displacement of the delivery piston in the direction of the third position to an intermediate position.

[0070] A further subject of the invention relates to a method for providing a bone cement dough from two starting components by means of a device according to one of the preceding embodiments, wherein a bone cement powder is stored in the interior as the first starting component and a fluid-conducting closed monomer liquid container filled with a monomer liquid as the second starting component is stored in the reservoir container, comprising the method steps: a. Providing the device in the first configuration; b. Axial displacement of the feed piston from the first position to the second position while fluidically opening the monomer liquid container; c. Flow of the monomer liquid from the reservoir into the hollow cylinder; d. Moving the device from the first configuration to the second configuration; e. Axial displacement of the feed piston from the second position towards the third position while conveying the monomer liquid from the hollow cylinder into the interior; f. Mixing the bone cement powder and the monomer liquid in the mixing unit while providing the bone cement dough.

[0071] The device may already be in the first configuration at the beginning of the method, for example, the device may already have been purchased by the user in the first configuration, or the user may bring the device into the first configuration at the beginning of the method.

[0072] If the device has a transport lock, it should be removed at the beginning of the procedure.

[0073] To open the monomer liquid container in a fluid-conducting manner, in process step b., while the device is in the first configuration, the delivery piston is moved from the first position, which can be regarded as the starting position of the delivery piston, to the second position. Since in the first configuration the delivery piston is connected to the opening means, preferably via a driver, the displacement of the delivery piston leads to a displacement of the opening means, which opens the monomer liquid container in a fluid-conducting manner.

[0074] After opening the monomer liquid container, in process step c., the monomer liquid flows essentially completely from the reservoir into the hollow cylinder of the transfer unit.

[0075] In order to convey the monomer liquid from the transfer unit, in particular the hollow cylinder of the transfer unit, into the interior of the mixing unit, the device is transferred from the first configuration to the second configuration.

[0076] The actual conveying of the monomer liquid takes place in process step e. by axially displacing the conveying piston from the second position towards the third position. The further the displacement is carried out towards the third position, the more of the monomer liquid contained in the hollow cylinder is conveyed into the mixing unit. Depending on the user's wishes, the displacement can therefore be carried out up to the third position or merely to an intermediate position between the second position and the third position. Preferably, the device, in particular the conveying piston, has a detachable control element which makes it easier for the user to precisely move the conveying piston into the hollow cylinder.The control element allows the feed piston to be moved to an intermediate position determined by the user between the second position and the third position, so that a predetermined amount of the monomer liquid can be pumped into the mixing unit, while a remaining part of the monomer liquid remains in the transfer unit and is not available for mixing the bone cement dough.

[0077] By conveying the monomer liquid into the mixing unit, the monomer liquid comes into contact with the bone cement powder inside the mixing unit. Mixing these two starting components produces the bone cement dough in the mixing system. Mixing can be achieved, for example, using a mixing rod that is reversibly moved axially within the mixing unit.

[0078] One embodiment of the method is characterized in that the device is moved from the first configuration to the second configuration by a rotational movement. In one embodiment, the configuration change occurs by rotating the delivery piston. In another embodiment, the configuration change occurs by rotating a ring. Both possibilities are described in more detail in the previous embodiments of the device.

[0079] The device is characterized in that it provides a bone cement dough made up of two starting components. A bone cement dough is understood to be a substance that is suitable in the field of medical technology for creating a stable connection between artificial joints, such as hip and knee joints, and bone material. Upon hardening, a bone cement dough becomes a bone cement. These bone cements are preferably polymethyl methacrylate bone cements (PMMA bone cements). PMMA bone cements have long been used in medical applications and date back to the work of Sir Charnley (cf. Charnley, J. Anchorage of the femoral head prosthesis of the shaft of the femur. J. Bone Joint Surg. 1960; 42, 28-30.). PMMA bone cements can be produced from a bone cement powder as the first starting component and a monomer liquid as the second starting component.With a suitable composition, the two starting components can be stored separately. When the two starting components are brought into contact, swelling of the polymer components of the bone cement powder creates a plastically deformable bone cement paste. This initiates radical polymerization of the monomer. As the monomer polymerization progresses, the viscosity of the bone cement paste increases until it completely hardens.

[0080] A bone cement powder is understood to be a powder comprising at least one particulate polymethyl methacrylate and / or a particulate polymethyl methacrylate copolymer. Examples of copolymers are styrene and / or methyl acrylate. In one embodiment, the bone cement powder can additionally comprise a hydrophilic additive that supports the distribution of the monomer liquid within the bone cement powder. In another embodiment, the bone cement powder can additionally comprise an initiator that initiates the polymerization. In another embodiment, the bone cement powder can additionally comprise an X-ray opaque. In yet another embodiment, the bone cement powder can additionally comprise pharmaceutically active substances, such as antibiotics.

[0081] The bone cement powder preferably comprises, as a hydrophilic additive, at least one particulate polymethyl methacrylate and / or a particulate polymethyl methacrylate copolymer, an initiator, and a radiopaque, or consists of these components. Further preferably, the bone cement powder comprises, or consists of, at least one particulate polymethyl methacrylate and / or a particulate polymethyl methacrylate copolymer, an initiator, a radiopaque, and a hydrophilic additive. Most preferably, the bone cement powder comprises, or consists of, at least one particulate polymethyl methacrylate and / or a particulate polymethyl methacrylate copolymer, an initiator, a radiopaque, a hydrophilic additive, and an antibiotic.

[0082] According to the invention, the particle size of the particulate polymethyl methacrylate and / or the particulate polymethyl methacrylate copolymer of the bone cement powder of the sieve fraction can correspond to less than 150 µm, preferably less than 100 µm.

[0083] According to the invention, the hydrophilic additive can be particulate and / or fibrous. In a further embodiment, the hydrophilic additive can be sparingly soluble, preferably insoluble, in methyl methacrylate. In a further embodiment, the hydrophilic additive can have an absorption capacity of at least 0.6 g of methyl methacrylate per gram of hydrophilic additive. In a further embodiment, the hydrophilic additive can comprise a chemical substance with at least one OH group. It can preferably be provided that the hydrophilic additive has covalently bonded OH groups on its surface. Examples of such preferred hydrophilic additives can be additives selected from the group comprising cellulose, oxycellulose, starch, titanium dioxide, and silicon dioxide, with pyrogenic silicon dioxide being particularly preferred.In one embodiment, the particle size of the hydrophilic additive of the sieve fraction can be less than 100 µm, preferably less than 50 µm, and most preferably less than 10 µm. The hydrophilic additive can be present in an amount of 0.1 to 2.5 wt.% based on the total weight of the bone cement powder.

[0084] According to the invention, the initiator may contain dibenzoyl peroxide or consist of dibenzoyl peroxide.

[0085] According to the invention, a radiopaque agent is understood to mean a substance that allows the bone cement to be made visible on X-ray images. Examples of radiopaque agents can include barium sulfate, zirconium dioxide, and calcium carbonate. According to the invention, the pharmaceutically active substance can comprise one or more antibiotics and, optionally, added cofactors for the one or more antibiotics. Preferably, the pharmaceutically active substance consists of one or more antibiotics and, optionally, added cofactors for the one or more antibiotics. Examples of antibiotics include gentamicin, clindamycin, and vancomycin. According to the invention, the monomer liquid can comprise the monomer methyl methacrylate or consist of methyl methacrylate.In one embodiment, the monomer liquid comprises, in addition to the monomer, an activator dissolved therein, such as N,N-dimethyl-p-toluidine, or consists of methyl methacrylate and N,N-dimethyl-p-toluidine.

[0086] The features disclosed for the device are also disclosed for the method and vice versa. Figures

[0087] The invention is further illustrated below by means of exemplary figures. The invention is not limited to the figures.

[0088] It shows Fig. 1 shows a schematic longitudinal section of an exemplary device for providing a bone cement dough comprising a mixing unit, a reservoir with a monomer liquid and a transfer unit, wherein the device is in a first configuration and a feed piston is arranged in a first position, Fig. 2 shows the device from Figure 1in a second position of the delivery piston, Fig. 3 the device from the Figures 1 and 2 in a second configuration and when conveying the monomer liquid from the transfer unit into the mixing unit, Fig. 4 the device from the Figures 1 to 3 when mixing the bone cement powder and the monomer liquid to provide the bone cement dough, Fig. 5 a schematic longitudinal section of another exemplary device for providing a bone cement dough comprising a mixing unit, a reservoir with a monomer liquid and a transfer unit, wherein the device is in a first configuration and a feed piston is arranged in a first position, Fig. 6 the device from Figure 5 in a second configuration, Fig. 7 the device from the Figures 5 and 6in an intermediate position of the feed piston, and Fig. 8 a flow diagram of a method for providing a bone cement dough. Description of the characters

[0089] Figure 1 shows a schematic longitudinal section of an exemplary embodiment of a device 100 for preparing a bone cement dough from two starting components in an initial state. The device 100 comprises a mixing unit 200, a reservoir 300, and a transfer unit 400, via which the mixing unit 200 and the reservoir 300 are or can be connected in a fluid-conducting manner.

[0090] The mixing unit 200 is used to mix the starting components of the bone cement dough and comprises an interior space 210 in which a bone cement powder 510 is stored as the first starting component of the bone cement dough to be prepared, as well as a mixing element 220 in the form of a mixing rod. The mixing element 220 is reversibly displaceable within the interior space 210 and rotatably mounted about a longitudinal axis, so that mixing blades 225 can ensure homogeneous mixing of the starting components. The mixing unit 200 is reversibly detachably connected to the remaining part of the device 100 via a thread 230, so that after the mixing unit 200 is separated, the bone cement dough provided therein can be applied from the mixing unit 200 to a desired location.

[0091] The reservoir 300 comprises a reservoir container 310 in which a fluid-conducting, closed monomer liquid container 320 in the form of an ampoule, in particular a glass ampoule, is stored. A monomer liquid 520 is stored within the monomer liquid container 320 as the second starting component of the bone cement dough.

[0092] The transfer unit 200 is arranged spatially between the mixing unit 200 and the reservoir 300. The transfer unit 200 comprises a hollow cylinder 410 and a delivery piston axially displaceable within the hollow cylinder 410, which cooperate as a piston-cylinder system for conveying the monomer liquid 520 from the hollow cylinder 410 into the interior space 210. For this purpose, the hollow cylinder 410 is fluidly connected to the interior space 210 via a connecting line 430 and, at least in the illustrated arrangement of the delivery piston 420 within the hollow cylinder 410, is fluidly connected to the reservoir 300 via a passage 330. The connecting line 460 between the transfer unit 400 and the mixing unit 200 is arranged in a loop with a high apex 465 in order to prevent an uncontrolled flow of the monomer liquid 520 through the connecting line 460 into the mixing unit 200, in particular the interior 210.In order to ensure that the monomer liquid 520 is conveyed as completely as possible from the hollow cylinder 410 into the interior space 210, the hollow cylinder 410 and the conveying piston 420 are cambered and the connecting element 460 is arranged at the lowest point of the hollow cylinder 410.

[0093] For fluid-conducting opening of the monomer liquid container 320, the device 100 has an opening means 430 in the form of a wedge. The opening means 430 is mounted axially displaceably above an ampoule head 325 of the monomer liquid container 320, so that an axial displacement of the opening means 430 can cause the ampoule head 325 to break off, thereby opening the monomer liquid container 320 in a fluid-conducting manner. In order to displace the opening means 430 in this way, it is Figure 1connected to the delivery piston 420 via a driver 440. This means that an axial displacement of the delivery piston 420 within the hollow cylinder 410 is transmitted directly to the opening means 430 via the driver 440. The device 100 is in Figure 1 thus arranged in a first configuration, wherein the delivery piston 420 is in a first position, its initial position.

[0094] Figure 2 shows the device Figure 1 , wherein the device 100 is still in the first configuration, but the delivery piston 420 is moved from its Figure 1shown first position was axially displaced in the hollow cylinder 410 into a second position. In the first configuration, as already described, a displacement of the delivery piston 420 is transferred directly via the driver 440 to the opening means 430. By displacing the delivery piston 420 into the second position, the opening means 430 was pressed against the ampoule head 325 of the monomer liquid container 320, which then broke off and thus opened the monomer liquid container 320 in a fluid-conducting manner. At the time shown, the monomer liquid 520 is flowing from the fluid-conductingly opened monomer liquid container 320 through the passage 330 into the hollow cylinder 410 of the transfer unit 400. In the second position of the delivery piston 420, the opening means 430 rests against a stop 435.The stop 435 blocks continued axial displacement of the opening means 430 in the direction intended for fluid-conducting opening of the monomer liquid container 320. In the first configuration of the device 100, continued displacement of the delivery piston 420 from the second position toward a third position is thus also prevented. Remaining the device 100 in the first configuration thus prevents, in particular unintentional, conveyance of the monomer liquid 520 from the hollow cylinder 410 into the mixing unit 200.

[0095] To prevent contamination of the bone cement dough to be provided with fragments, in particular glass splinters, of the fluid-conductingly open monomer liquid container 320, a filter element 340 is located within the reservoir 300, which retains the fragments in the reservoir 300. In the embodiment, in particular, the ampoule head 325 is retained within the reservoir 300 by the filter element.

[0096] Figure 3 shows the device 100 from the Figures 1 and 2, wherein the device 100 is in a second configuration. In the second configuration, the delivery piston 420 is no longer connected to the opening means 430 via the driver 440, so that the delivery piston 420 is no longer restricted in its freedom of movement within the hollow cylinder 410 by the opening means 430 resting against the stop 435. The device 100 was moved from the first configuration to the second configuration via a rotational movement 470 (indicated by an arrow) of the delivery piston 420. Due to the rotational movement 470, the driver 440 is no longer engaged with the opening means 430.At the time shown, the delivery piston was displaced axially in the hollow cylinder 410 from its second position towards a third position, which on the one hand closed the passage 330 in a fluid-conducting manner and on the other hand initiated a conveyance of the monomer liquid 520 from the transfer unit 400 via the connecting line 460 into the mixing unit 200.

[0097] Figure 4 shows the device 100 from the Figures 1 to 3 in providing the bone cement dough 500. The device 100 is still located as in Figure 3, in the second configuration, wherein the delivery piston 420 was moved to the third position. This resulted in a substantially complete delivery of the monomer liquid 520 (only residues remaining in the connecting line 460) into the mixing unit 200, where the two starting components were mixed to form the bone cement dough 500 by repeatedly moving and rotating the mixing element 220. The bone cement dough 500 is thus ready for dispensing to a desired location after the mixing unit 200 is separated from the rest of the device 100.

[0098] Figure 5 shows a schematic longitudinal section of a further exemplary embodiment of a device 100' for providing a bone cement dough from two starting components in an initial state.

[0099] The embodiment according to Figure 5largely corresponds to the embodiment and its use described above and illustrated in the preceding figures, so that reference is made to the above description to avoid repetition. A structure repeated from the description of the preceding figures has the same reference numeral with an apostrophe.

[0100] The device 100' is located, analogously to device 100 in Figure 1 , in a first configuration and the delivery piston 420' is in the first position.

[0101] The device 100' has a releasable transport lock 110 on the opening means 430', which prevents an unintentional displacement of the opening means 430' and thus fluid-conducting opening of the monomer liquid container 320'. Furthermore, the device 100' comprises, in contrast to the device 100 of the Figures 1 to 4several, in particular 4, control elements 450 detachable from the feed piston 420'. The control elements 450 allow a user of the device 100' to displace the feed piston 420' only to an intermediate position predetermined by the individual control element 450 between the second position and the third position of the feed piston 420' in the hollow cylinder 410' and thus to feed the monomer liquid 520' located there into the mixing unit 200' only in a predetermined proportion. In the embodiment of the device 100' shown, the driver 440' is arranged on a ring, in particular a cap-like ring, which is rotatable around the feed piston 420'. Moving the device 100' from the first configuration to a second configuration is thus achieved by rotating the ring 445, and not, as in the case of the device 100, from the Figures 1 to 4 by rotating the delivery piston 420 itself.

[0102] Figure 6shows the device 100' from Figure 5 after a fluid-conducting opening of the monomer liquid container 320'. For this purpose, the transport lock 110 was removed and the delivery piston 420' was axially displaced from the first position to a second position within the hollow cylinder 410'. At the time shown, the monomer liquid 520' is already essentially completely in the hollow cylinder 410', and the delivery piston 420' was separated from the opening means 430 by a rotational movement 470' (indicated by an arrow) of the ring 445, which transferred the device 100' from the first configuration to a second configuration.

[0103] Figure 7 shows the device 100' from the Figures 5 and 6 , wherein the device 100' continues to be in the second configuration and the delivery piston 420' is moved from the second position into Figure 6to an intermediate position between the second position and a third position. In the embodiment shown, the intermediate position is determined by the presence of one of the control elements 450, which prevents continued insertion of the delivery piston 420' into the hollow cylinder 410' into the third position. For this purpose, the two lower control elements 450 (cf. Figure 5 or 6) is removed, and the previously third control element from the bottom defines the intermediate position. This enables a predetermined conveyance of only a portion of the monomer liquid 520' from the transfer unit 200' into the mixing unit, while the remaining portion of the monomer liquid 520' remains in the hollow cylinder 410', at least until the remaining control element 450 is removed from the conveying piston 420' and the conveying piston 420' is further moved into the third position. In this way, a specific mixing ratio of the starting components in the bone cement dough can be achieved.

[0104] Mixing and preparing the bone cement dough can be carried out analogously to the embodiment of the device 100 of the Figures 1 to 4 can be achieved.

[0105] Figure 8 shows a method 600 for providing a bone cement dough 520 from two starting components by means of the above-described device 100, 100' from the Figures 1 to 4 and 5 to 7 comprising process steps 610 to 660.

[0106] In the interior space 210, 210' of the mixing unit 200, 200', a bone cement powder 510, 510' is stored as the first starting component, and in the reservoir container 310, 310' of the reservoir 300, 300', a monomer liquid container 320, 320' filled with a monomer liquid 520, 520' as the second starting component is stored.

[0107] In a method step 610, the device 100, 100' is provided in the first configuration. The first configuration can, for example, be installed by a user of the device 100, 100', or the user of the device 100, 100' can, for example, already have acquired it in the first configuration.

[0108] If the device 100, 100' has a transport lock 110, this should preferably be removed before the subsequent process steps.

[0109] In a method step 620, the delivery piston 420, 420' is axially displaced from the first position, which is preferably the starting position of the delivery piston 420, 420', into the second position, with the monomer liquid container 320, 320' being opened in a fluid-conducting manner. For clarification, it should be noted again that the device 100, 100' is in the first configuration for this method step, so that the displacement of the delivery piston 420, 420' is transmitted to the opening means 430, 430'. Preferably, the displacement of the delivery piston 420, 420' is effected by the user of the device 100, 100' exerting force on the delivery piston 420, 420'. Alternatively or additionally, the displacement of the delivery piston 420, 420' can also be triggered by a negative pressure applied to the device 100, 100', in particular to the interior 210, 210'.This also applies to any further displacement of the delivery piston 420, 420' during the process 600.

[0110] In a method step 630, the monomer liquid 520, 520' flows from the reservoir 300, 300' into the hollow cylinder 410, 410'. Preferably, the flow of the monomer liquid 520, 520' occurs according to gravity. The device 100, 100' must be spatially aligned accordingly.

[0111] In a method step 640, the device 100, 100' is transferred from the first configuration to the second configuration. This preferably occurs by a rotational movement 470, 470', preferably of the delivery piston 420 or the ring 445.

[0112] In a method step 650, the delivery piston 420, 420' is axially displaced from the second position toward the third position, conveying the monomer liquid 520, 520' from the hollow cylinder 410, 410' into the interior 210, 210'. The further the delivery piston 420, 420' is displaced toward the third position, the more of the monomer liquid 520, 520' located in the hollow cylinder 410, 410' is conveyed into the interior 210, 210', until the third position is reached, when the monomer liquid 520, 520' would be or is essentially completely conveyed. The amount of monomer liquid 520, 520' conveyed can thus be determined by the user of the device 100, 100'. The user can be assisted in this process by using control elements 450.

[0113] In a method step 660, the bone cement powder 510, 510' and the monomer liquid 520, 520' are mixed to provide the bone cement dough 500.

[0114] The bone cement dough 500 can then be discharged from the mixing unit 200, 200' to the location desired by the user. For this purpose, the mixing unit 200, 200' can preferably be separated from the remaining device 100, 100' and discharged from the interior 210, 210' by means of a discharge device, preferably by means of a discharge piston displaceable within the interior 210, 210'. Reference symbol

[0115] 100, 100'Device 110Transport lock 200, 200'Mixing unit 210, 210'Interior 220, 220'Mixing element 225, 225'Mixing blade 230, 230'Thread 300, 300'Reservoir 310, 310'Reservoir container 320, 320'Monomer liquid container 325, 325'Ampoule head 330, 330'Feedthrough 340, 340'Filter element 350Transport lock 400, 400'Transfer unit 410, 410'Hollow cylinder 420, 420'Feed piston 430, 430'Opening means 435, 435'Stop 440, 440'Driver 445Ring 450Control element 460, 460'Connecting line 465, 465'Apex 470, 470'Rotational movement 500Bone cement dough 510, 510'Bone cement powder 520, 520'Monomer liquid 600Procedure 610Provide 620Displace 630Flow 640Deliver 650Displace 660Mix

Claims

1. Device (100, 100') for providing a bone cement dough (500) from two starting components, comprising a mixing unit (200, 200') with an interior space (210, 210') in which a bone cement powder (510, 510') is stored or can be stored as the first starting component, a reservoir (300, 300') with a reservoir container (310, 310') in which at least one fluid-conducting closed monomer liquid container (320, 320') filled with a monomer liquid (520, 520') is stored or can be stored as the second starting component, a transfer unit (400, 400') comprising a hollow cylinder (410, 410') and a delivery piston (420, 420') which is axially displaceable in the hollow cylinder (410, 410'), wherein the Mixing unit (200, 200') and the reservoir (300, 300') are or can be connected to one another in a fluid-conducting manner via the hollow cylinder (410, 410'), wherein the monomer liquid container (320, 320') in the device (100, 100') can be opened in such a way that the monomer liquid (520,520') can flow from the reservoir (300, 300') into the hollow cylinder (410, 410') via a passage (330, 330') and can be conveyed from the hollow cylinder (410, 410') into the interior (210, 210') by axial displacement of the delivery piston (420, 420') in the hollow cylinder (410, 410'), , characterized in thatin a first configuration of the device (100, 100'), the delivery piston (420, 420') is connected to an opening means (430, 430'), so that an axial displacement of the delivery piston (420, 420') from a first position to a second position pushes the opening means (430, 430') against the monomer liquid container (320, 320'), so that the monomer liquid container (320, 320') can be opened in a fluid-conducting manner by the opening means (430, 430') and the monomer liquid (520, 520') can flow from the reservoir (300, 300') via the passage (330, 330') into the hollow cylinder (410, 410'), and that in a second configuration of the device (100, 100'), the delivery piston (420, 420') is separated from the opening means (430, 430'), so that the monomer liquid (520, 520') is discharged from the hollow cylinder (410, 410') into the interior (210,210') is eligible., 2. Device (100, 100') according to claim 1, wherein in the first configuration the delivery piston (420, 420') is only displaceable between the first position and the second position.

3. Device (100, 100') according to claim 2, wherein in the first configuration the opening means (430, 430') abuts against a stop (435, 435') in the second position of the delivery piston (420, 420') so that the continued axial displacement from the second position towards the third position is prevented.

4. Device (100, 100') according to one of the preceding claims, wherein the opening means (430, 430') is a wedge.

5. Device (100, 100') according to claim 4, wherein the wedge has at least one opening so that the monomer liquid (520, 520') can flow through the opening and the passage (330, 330') from the reservoir (300, 300') into the hollow cylinder (410, 410').

6. Device (100, 100') according to one of the preceding claims, wherein the monomer liquid container (320, 320') is an ampoule and is stored in the reservoir container (310, 310'), wherein the opening means (430, 430') is arranged axially above an ampoule head (325, 325') of the ampoule, so that when the delivery piston (420, 420') is moved from the first position to the second position in the first configuration of the device (100, 100'), the opening means (430, 430') can be pressed against the ampoule head (325, 325') and the ampoule can thus be opened in a fluid-conducting manner.

7. Device (100, 100') according to one of the preceding claims, wherein the delivery piston (420, 420') and the opening means (430, 430') are connected to one another in the first configuration via a driver (440, 440').

8. Device (100, 100') according to claim 7, wherein the driver (440, 440') is separated from the opening means (430, 430') when the device (100, 100') is moved from the first configuration to the second configuration.

9. Device (100) according to claim 8, wherein the movement of the device (100) from the first configuration to the second configuration can be achieved by rotating the delivery piston (420) about a delivery piston longitudinal axis.

10. Device (100') according to claim 8, wherein the driver (440') is arranged on a ring (445) around the delivery piston (420'), so that the device (100') can be moved from the first configuration to the second configuration by rotating the ring (445) around the delivery piston (420').

11. Device (100') according to one of the preceding claims, wherein the device (100') has a transport lock (110) which prevents unintentional displacement of the opening means (430').

12. Device (100') according to one of the preceding claims, wherein the delivery piston (420') has at least one detachable control element (450) which limits the displacement of the delivery piston (420') between the second position and the third position to an intermediate position.

13. Device (100, 100') according to one of the preceding claims, wherein the delivery piston (420, 420') closes the passage (330, 330') in a fluid-conducting manner when axially displaced from the second position towards the third position.

14. A method (600) for preparing a bone cement dough (500) from two starting components by means of a device (100, 100') according to one of claims 1 to 13, wherein a bone cement powder (510, 510') is stored in the interior (210, 210') as the first starting component and a fluid-conducting closed monomer liquid container (320, 320') filled with a monomer liquid (520, 520') is stored in the reservoir container (310, 310') as the second starting component, comprising the method steps: a. Providing (610) the device (100, 100') in the first configuration; b. Axial displacement (620) of the feed piston (420, 420') from the first position to the second position while fluid-conductingly opening the monomer liquid container (320, 320'); c. Flowing (630) the monomer liquid (520, 520') from the reservoir (300, 300') into the hollow cylinder (410, 410'); d. Moving (640) the device (100, 100') from the first configuration to the second configuration; e.Axial displacement (650) of the feed piston (420, 420') from the second position toward the third position while conveying the monomer liquid (520, 520') from the hollow cylinder (410, 410') into the interior (210, 210'); f. Mixing (660) the bone cement powder (510, 510') and the monomer liquid (520, 520') in the mixing unit (200, 200') while providing the bone cement dough (500).

15. The method (600) according to claim 14, wherein the movement (640) of the device (100, 100') from the first configuration to the second configuration occurs by a rotational movement (470, 470').

Images